Summary
The Director level Project Team Member leads cross functional associates (i.e. PCS Target Team) to develop and implement integrated nonclinical toxicology study plans, drafts regulatory responses and all required submission documentation and manages the respective project communication strategy within PCS and Novartis
About the Role
- Leads PCS Target Teams to design, integrate and interpret results of nonclinical safety assessment program including impact to drug development and/or project timeline
- Represents PCS on cross functional R&D project teams to design appropriately compliant and scientifically relevant nonclinical safety package
- Recognize the need for a "fit for purpose and modality” nonclinical program as needed and collaborate with line functions outside of PCS to accomplish this goal
- Participates in internal Novartis initiatives to improve use of nonclinical/translational safety data for drug development decisions.
- Manages communications and builds relationships between PCS and R&D project teams
- Negotiates with Global Health Authorities (HA) worldwide regarding safety issues, scientific interpretation and acceptability nonclinical safety package to support clinical trials and market approval.
- Responsible for authoring nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval
- May evaluate in/out-licensing opportunities and carries out technical Due Diligence activities upon request.
- Participates or Leads internal and/or external cross-functional groups on key initiatives focused on PCS objectives and/or current nonclinical safety topics.
- Mentors colleagues on drug development strategy and project-related matters
Essential Requirements:
- Minimum of 5 years experience as a nonclinical safety Project Team member; Demonstrated experience in the preclinical development of small molecule, biotherapeutics and/or gene and cell therapies and the safety issue awareness of these modalities.
- 8+ years experience in a nonclinical drug development scientific discipline (e.g. study director, project team toxicologist or pharmacologist).
- Demonstrated experience in direct or written communication of strategy and data to global health authorities, supporting clinical development and market approval.
- Knowledge of drug development strategy for immunomodulatory drugs
- Leadership in cross-industry organizations (discipline-related or related to drug development).
- Excellent interpersonal, leadership, organizational skills (e.g. planning and time management) and teamwork skills. Excellent oral and written communication and influencing skills. Highly efficient, self-motivated, flexible and able to work independently and efficiently under time constraints.
- Ability to focus and work on several projects simultaneously and to effectively manage conflicting expectations from the line unit, TA Strategy team and project teams in a matrix management environment.
- Customer focused thinking. Recognized ability to represent PCS on Novartis cross functional decision boards or other cross functional project teams.
- Recognized expertise in technical and scientific problem solving in a project driven, multi-disciplinary international environment.
- Ability to mentor and coach
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
